SHELTON, CT / ACCESSWIRE / December 3, 2019 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company"), a global leader in nanomedicines against viruses, reports that Dr. Anil R. Diwan, co-founder, President and Chairman of the Board of the Company, has provided a commitment for $2 million in debt to the Company.
This commitment for $2 million comes at a critical juncture for the Company and provides for its immediate cash flow requirements. Since the Company has managed to scale down its cash expenditure rate to under $1.6 million per quarter, it is expected that this commitment will provide a substantial runway for the Company.
The Company anticipates completing additional financing soon based on a secondary public offering of the Company's common stock to further bolster its cash position as it is working on progressing its first drug candidate into human clinical trials.
Approximately $1 million will be made available immediately upon execution of a definitive agreement and an additional $1 million will be made available in a second tranche in January 2020, or later, at the Company's discretion. The Company is not required to accept the second tranche if it does not need the funds at that time. The loan will be for a term of one year and will bear an interest rate of 1% per month. A commitment fee of 10,000 shares of Series A preferred stock of the Company will be payable upon execution of the agreement. The loan will be secured by a mortgage on the Company's facility at 1 Controls Drive, Shelton, CT. The terms of the loan were accepted by the independent members of the Company's Board of Directors, with Dr. Diwan recused from any discussions.
The Company is advancing its lead drug candidate, NV-HHV-101, towards filing its first IND application for the topical dermal treatment of singles rash as its first indication. As the Company advances its efforts, it will need to raise additional financing to complete the IND application process and to conduct initial human clinical trials.
The Company's first drug candidate, NV-HHV-101, under the HerpeCide™ program, is progressing towards human clinical trials satisfactorily. In light of the successful results that have become available so far in the IND-enabling pre-clinical development studies as reported by the Company in its press releases, the Company has been in the process of interviewing Contract Research Organizations (CRO's) that can perform human clinical trials of the NV-HHV-101 skin cream towards approval for the dermal topical treatment of shingles rash, as our first indication.
The Company has previously filed a pre-IND application for NV-HHV-101 for the dermal topical treatment of shingles rash with the US FDA and has received favorable responses on our potential study designs.
About 500,000 to 1 million episodes of herpes zoster (shingles) occur annually in the United States alone. In spite of the new Shingrix™ vaccine, the market size for a therapeutic for shingles is estimated to be in excess of $1 billion dollars. There is currently no approved drug against shingles, PHN, or chickenpox, indicating an unmet medical need.
In a human skin organ culture model of VZV infection, this drug candidate, NV-HHV-101, has been shown to be highly effective against VZV. This work was performed by Professor Jennifer Moffat at the SUNY Upstate Medical University, Syracuse, NY.
Since these efficacy studies were performed using human skin, and were complemented with histological observations regarding safety, the Company believes that this work has laid the foundation towards success in human clinical trials.
The Company is working on developing drugs against several indications in our HerpeCide™ program. The market size for our immediate target drugs in the HerpeCide™ program is estimated into billions of dollars in reports prepared for the Company. The Company believes that its dermal topical cream for the treatment of shingles rash will be its first drug heading into clinical trials. The Company believes that additional topical treatment candidates in the HerpeCide™ program, namely, HSV-1 "cold sores" treatment, and HSV-2 "genital ulcers" treatment are expected to follow the shingles candidate into IND-enabling development and then into human clinical trials.
NanoViricides, Inc. (www.nanoviricides.com) is a development stage company that is creating special purpose nanomaterials for antiviral therapy. The Company's novel nanoviricide® class of drug candidates are designed to specifically attack enveloped virus particles and to dismantle them. Our lead drug candidate is NV-HHV-101 with its first indication as dermal topical cream for the treatment of shingles rash. The Company is also developing drugs against a number of viral diseases including Oral and Genital Herpes, viral diseases of the eye including EKC and Herpes Keratitis, H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others. The Company's technology is based on broad, exclusive, sub-licensable, field licenses to drugs developed in these areas from TheraCour Pharma, Inc. This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company's expectations include, but are not limited to, those factors that are disclosed under the heading "Risk Factors" and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in preclinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products.
FDA refers to US Food and Drug Administration.
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SOURCE: NanoViricides, Inc.